The following data is part of a premarket notification filed by Invivo Research, Inc. with the FDA for Modular Telemetry System For The Vision Telepak, Model 20701.
| Device ID | K043354 |
| 510k Number | K043354 |
| Device Name: | MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Contact | Neil Battiste |
| Correspondent | Neil Battiste INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-06 |
| Decision Date | 2005-01-10 |
| Summary: | summary |